Jose 2007.
Study characteristics | ||
Methods | Design: cross‐over Duration: 6 weeks Assessment: baseline, 2 weeks, 4 weeks, post‐intervention Country: India |
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Participants | Pain condition: diabetic peripheral neuropathy Population: adults with type 2 diabetes and diabetic peripheral neuropathy Minimum pain intensity: ≥ 50 on 0‐100 scale Inclusion criteria
Exclusion criteria
Total participants randomised: 75 Age in years (median, range): 56 (50‐62) Gender: 30/75 were female Pain duration in years (median, range): 12 (4‐24) |
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Interventions | Lamotrigine 50‐200 mg
Amitriptyline 10‐50 mg
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Outcomes | Pain intensity AEs Withdrawal |
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Missing data methods | ITT with LOCF | |
Funding source | NR | |
Conflicts of interest | None declared | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomised using random number tables by block randomisation |
Allocation concealment (selection bias) | Unclear risk | Allocation procedure unclear |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind, study drugs appeared identical and matched dosing schedules |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Self‐reported outcomes from blinded participants |
Incomplete outcome data (attrition bias) All outcomes | High risk | Use ITT and LOCF. Unequal attrition across arms ‐ 100% of participants who completely dropped out did so from the 1st period in one intervention arm. Attrition Total: 7/53 (13.2%) Lamotrigine 50‐200 mg: 0/53 (0.0%) Amitriptyline 10‐50 mg: 7/53 (13.2%) |
Selective reporting (reporting bias) | Unclear risk | No protocol or trial registration found |
Other bias | Low risk | No other sources of bias were identified. |